Endovascular Stent-Grafts - India CDSCO Medical Device Registration

Endovascular Stent-Grafts is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000191_b0d6c28fca712efb1fc3b2daacdde2a9_0666f00f5ed2dba31b7e5d2862392958. This device is marketed under the brand name Torcon NB® Advantage Catheter, Royal Flush® Plus High Flow Catheter & Torcon NB® Advantage Catheter. The license holder is M/s Cook India Medical Devices Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Endovascular Stent-Grafts

UID: IMP/MD/2018/000191_b0d6c28fca712efb1fc3b2daacdde2a9_0666f00f5ed2dba31b7e5d2862392958

Brand Name

Torcon NB® Advantage Catheter, Royal Flush® Plus High Flow Catheter & Torcon NB® Advantage Catheter

License Holder

M/s Cook India Medical Devices Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

It is indicated for use with the Zenith AAA Endovascular Graft family of products, including the Zenith Flex AAA Endovascular Graft, Zenith Alpha Abdominal Endovascular Graft, Zenith Low Profile AAA Endovascular Graft, Zenith Renu Ancillary Graft, Zenith Fenestrated AAA Endovascular Graft, Zenith Universal Distal Body Endovascular Graft, Zenith Flex AUI, or Zenith Branch, during either a primary or a secondary procedure in patients who have adequate iliac/femoral access compatible with the required introduction systems. The graft is used in combination with these products for the endovascular treatment of abdominal aortic and aorto-iliac aneurysms

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